Breast implants with integrated transponders

ABSTRACT

The present invention provides, in various embodiments, a breast implant with an RFID transponder embedded therein, so that the implant can be conveniently identified while inside the human body, and methods of making the same.

RELATED APPLICATIONS

This application claims the benefit of, and priority to, U.S.Provisional Application No. 61/701,910, filed Sep. 17, 2012, entitled“Breast Implants With Integrated Transponders,” which is incorporatedherein by reference in its entirety.

BACKGROUND

Currently there is no accurate, adequate, practical or economical way toidentify a breast implant that is already inside the body of a patient.This void has developed into a serious complication for the fulfillmentof recalls and controls, when the patients do not have theidentification information for their implants, or when medical recordsare not available. More specifically, and relating to defective breastimplants which have been already found in the market, many women aroundthe world face the problem of having no information regarding the breastimplants inside them, and no way of finding out if they need to beexplanted or not, without undergoing an actual explanation procedure.Thus, there is a need in the art for breast implants that, whenimplanted, can be easily and accurately identified from outside thebody.

SUMMARY

The present invention relates to a breast implant designed to add to orreplace volume of the breast, which includes a unique device identifier(UDI) therein, providing post-implantation device recognition andtraceability. In preferred embodiments, the UDI is a passive RFID (radiofrequency identification) transponder, which is embedded within theimplant filling at the time of manufacture.

In various embodiments, the present invention provides breast implantcomprising a silicone elastomer shell with an opening covered by apatch, a silicone gel filling said shell, and a transponder disposedwithin said filling and positioned proximal to said patch.

The silicone elastomer shell is formed by preparing a silicone elastomerdispersion; dipping a mold into said dispersion one or more times,forming one or more silicone elastomer layers; and removing the one ormore layers from the mold, forming a silicone elastomer shell having anopening where the mold was removed.

In some embodiments, the transponder is placed within the shell throughsaid opening. Said opening is then covered with a patch and the patchedshell is filled with a silicone gel through a filling hole in the patch.

In other embodiments, said opening is covered with a patch, the patchedshell is filled with a silicone gel through a filling hole in the patch,and the transponder is placed within the patched shell through saidfilling hole.

In still further embodiments, said opening is covered with a patch, thetransponder is placed within the patched shell through a filling hole inthe patch, and the patched shell is filled with a silicone gel throughsaid filling hole.

The manufacturing process further includes applying a vacuum to thesilicone gel-filled shell, removing air bubbles and positioning thetransponder proximal to said patch; sealing the filling hole; and curingthe silicone gel, wherein said gel curing further positions thetransponder proximal to said patch and comprises heating thesilicone-gel filled shell with transponder therein to a temperature ofabout 140° C. to 200° C. for up to about 8 hours.

In some embodiments, the breast implant with integrated transponder isfurther sterilized at a temperature of about 120° C. to 150° C. for upto about 36 hours.

Additional features and advantages of the present invention aredescribed further below. This summary section is meant merely toillustrate certain features of the invention, and is not meant to limitthe scope of the invention in any way. The failure to discuss a specificfeature or embodiment of the invention, or the inclusion of one or morefeatures in this summary section, should not be construed to limit theinvention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofthe preferred embodiments of the application, will be better understoodwhen read in conjunction with the appended drawings. For the purposes ofillustrating the device of the present application, there are shown inthe drawings preferred embodiments. It should be understood, however,that the application is not limited to the precise arrangements andinstrumentalities shown. In the drawings:

FIG. 1 shows a flowchart of exemplary processes involved inmanufacturing the breast implants of the present invention, according tosome embodiments.

FIG. 2 shows a schematic diagram of breast implants of the presentinvention, according to some embodiments, illustrating exemplaryplacement of a microchip/transponder.

DETAILED DESCRIPTION

The present invention provides, in various embodiments, a breast implantwith an RFID transponder embedded therein, so that the implant can beconveniently identified while inside the human body, and methods ofmaking the same. The transponder contains a unique identification codeand/or implant-specific information that is readily accessible, forexample, by an external handheld scanner. In some embodiments,identification information from the transponder can be used to accessone or more databases containing further information (regarding thespecific breast implant, the specific patient, etc.).

FIG. 1 shows an exemplary flowchart of the different processes involvedin the manufacturing of a breast implant of the present invention,according to some embodiments. The processes affected by inclusion of atransponder are highlighted, and points where the transponder isadded/fixed/verified are marked with an asterisk.

In some embodiments, the breast implant comprises a silicone elastomershell. As shown in FIG. 1, this shell may be formed by preparing/mixinga silicone elastomer dispersion, and dipping a mold or mandrel into thedispersion. Multiple dip coats may be used to obtain a multilayeredshell, and different dispersions may be used for different dip coats.For example, a colored barrier layer may be added to the shell, asdescribed in U.S. application Ser. No. 13/412,221. The shell is thencured and removed/stripped from the mold.

The aperture (open part of the shell where the mold was removed) is thenpatched, for example, with a piece of silicone elastomer similar to thecured shell. In some embodiments, the transponder is introduced into thebreast implant during the shell patching (through the opening in theshell before the shell is patched). The patch is preferably secured byhigh pressure and heat. Alternatively, an adhesive or other method maybe used to secure the patch. The patched silicone elastomer shell may bedried and cured, and is then filled (e.g., by a syringe) through a holein the patch system (including the area where the patch joins with theshell) to a predetermined weight with fluid or gel. In some embodiments,the transponder is added during the silicone gel filling, through thehole used for the silicone gel filling. As shown in FIG. 1, in someembodiments, a highly viscous and highly elastic silicone gel is mixedand used (uncured) for filling the breast implant. The silicone gel mayinclude a platinum catalyst. The filled implant is then placed in avacuum chamber, where it undergoes one or more cycles of vacuum. Ifthere are any bubbles still visible, additional vacuum cycles may beadded.

The hole through which the implant was filled is then sealed (e.g., withan RTV silicone adhesive), and the silicone gel is cured. Preferably,the gel curing comprises high temperature curing (e.g., about 160° C.).In some embodiments, the implant may be filled with liquid or alternatefillers, which do not need further curing or vacuum cycles. The breastimplant may then be cooled down to room temperature and placed inprimary packaging (e.g., a double pack comprising a pair of implants).Sterilization may then be performed. Sterilization is preferablyperformed using dry heat (e.g., about 120 to 130° C. for about 24 to 48hours). Alternatively, the implant may be sterilized using othersterilization methods, such as ethylene oxide.

Product labeling and secondary packaging processes are then performedbefore the final release of the product. In some embodiments, forexample, product labeling assigns a serial number to the implant, andstores the serial number with information about the associated implantin a computer database (e.g., in an ERP system). Secondary packagingassigns the transponder identification code (e.g., 16 digit code) withthe serial number of the implant. Product final release verifies thatthe transponder identification code matches the serial number of theimplant. In other embodiments, different labeling/packaging processesmay be used, as long as they match the transponder identification numberto the serial number of each device.

Notably, Applicant has determined that the placement of the transponderwithin the breast implant is important for safe and effective functionof the invention. For example, in some embodiments, the transponder maybe affixed to the breast implant shell. However, the transponder isfragile and could break and/or could puncture the implant shell, thus itis preferred to place the transponder in a stronger part of the product.Accordingly, in other, more preferred embodiments, the transponder issuspended within the implant filling, close to the patch.

As indicated in FIG. 1, the transponder (microchip) can be added to theimplant at different parts of the manufacturing process. For example, asshown in FIG. 2, the transponder can be incorporated during the ShellPatching (through the opening in the shell before patching; 1 b).Alternatively, the transponder can be incorporated during the SiliconeGel Filling (through the hole in the patch system used for silicone gelfilling; 1 a).

In preferred embodiments, the transponder in the silicone gel is freefloating, but in close proximity to the patch, which is at the back sideof the implant (FIG. 2; 2 a, 2 b). Accordingly, once implanted, thetransponder will be farthest from the exterior of the patient, which canprotect the transponder and also ensure that it will not be felt (e.g.,under the patient's skin when touched). The density of the silicone gelmixed for the implant filling is thus chosen so that the transponderwill float in the silicone gel near the surface (the patch area). Thetransponder placement in the silicone filling gel at the back of thepatch system is adjusted/fixed during the vacuum process (FIG. 2; 4 a, 4b), and is verified when the filling hole is sealed.

Preferably, the transponder is added before the silicone gel is cured,so that is secured by the silicone. If the transponder is added aftercuring, it will break the gel when it is inserted and will not bewell-integrated. The transponder placement in the silicone gel near thepatch is further adjusted/fixed during the gel curing process (FIG. 2; 3a, 3 b). Advantageously, when the gel is cured with the transponderembedded therein, the transponder is flexibly fixed in the gel, and likea rubber band will come back to the same location even when the implantis manipulated/deformed and the transponder is moved therein.

As described above and shown in FIG. 1, several breast implantmanufacturing steps involve high temperatures, and high and lowpressures. For example, gel curing may use a temperature up to about200° C. (e.g., between 120° C. and 190° C.) for up to 8 hours.Sterilization may use a temperature up to about 150° C. (e.g., between110° C. and 145° C.) for up to 48 hours. Transponders integrated withinthe implants as described herein, must be able to withstand suchmanufacturing conditions.

Advantageously, the present invention uses a high temperature-stableglass encapsulated transponder, which can withstand temperatures up to210° C. (+20° C.) and can be integrated into the body of the breastimplant during the manufacture of the implant without loss of functionthereafter. Such transponders are described in co-pending U.S.application Ser. No. 14/027,896, entitled “High TemperatureTransponders,” which is incorporated herein by reference in itsentirety. In addition to their resistance to heat changes, thesetransponders provide good shock resistance, long term reliability, longrange sensitivity, and small size, among other advantages.

While there have been shown and described fundamental novel features ofthe invention as applied to the preferred and exemplary embodimentsthereof, it will be understood that omissions and substitutions andchanges in the form and details of the disclosed invention may be madeby those skilled in the art without departing from the spirit of theinvention. Moreover, as is readily apparent, numerous modifications andchanges may readily occur to those skilled in the art. Hence, it is notdesired to limit the invention to the exact construction and operationshown and described and, accordingly, all suitable modificationequivalents may be resorted to falling within the scope of the inventionas claimed. It is the intention, therefore, to be limited only asindicated by the scope of the claims appended hereto.

1-7. (canceled)
 8. A breast implant, comprising: a shell comprising oneor more silicone layers, the shell forming a cavity with an opening; asilicone gel disposed in the cavity; a patch covering the opening; and atransponder disposed in the silicone gel and positioned proximal to thepatch.
 9. The breast implant of claim 8, wherein the transponder is anRFID transponder containing an identification code.
 10. The breastimplant of claim 9, wherein the implant is enclosed in packaging, andthe packaging associates a unique identification number of the implantwith the identification code of the transponder.
 11. The breast implantof claim 8, wherein the shell comprises multiple silicone elastomerlayers.
 12. The breast implant of claim 8, wherein the shell includes acolored barrier layer.
 13. The breast implant of claim 8, wherein thetransponder is glass encapsulated.
 14. The breast implant of claim 8,wherein the transponder is capable of functioning up to a temperature of190° C. to 230° C.
 15. A breast implant, comprising: a shell forming acavity with an opening; a cured silicone gel disposed in the cavity; apatch sealing the opening; and a transponder flexibly fixed within thesilicone gel radially inward of the patch.
 16. The breast implant ofclaim 15, wherein the patch is heat-sealed to the shell.
 17. The breastimplant of claim 15, wherein the patch is sealed to the shell with anadhesive.
 18. The breast implant of claim 15, wherein the transponder isconfigured to withstand temperatures up to 210° C.
 19. The breastimplant of claim 15, wherein the transponder is a hightemperature-stable radio-frequency transponder.
 20. The breast implantof claim 15, wherein the breast implant is enclosed in sterilepackaging.
 21. The breast implant of claim 20, wherein the packaging isa primary packaging that is disposed in a secondary packaging, and thesecondary packaging associates a unique identification number of thebreast implant with an identification code of the transponder.
 22. Abreast implant, comprising: a shell comprising one or more siliconelayers, the shell forming a cavity with an opening; a silicone gelfilling the cavity; a patch sealing the opening; and a transponderembedded within the silicone gel.
 23. The breast implant of claim 22,wherein the transponder is stable up to a temperature of 190° C. to 230°C. without loss of function.
 24. The breast implant of claim 22, whereinthe patch is heat-sealed to the shell.
 25. The breast implant of claim22, wherein the transponder is a passive RFID transponder.
 26. Thebreast implant of claim 22, wherein the breast implant includes a uniqueidentification number associated with an identification code of thetransponder.
 27. The breast implant of claim 22, wherein the shellcomprises multiple silicone elastomer layers including a colored barrierlayer.